FDA.reportPublic FDA data

Inon Ace Tablets

Manufacturer
Sato Pharmaceutical Co., Ltd.
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:59:47

Label at a glance#

ProductInon Ace
Active ingredientMAGNESIUM HYDROXIDE, SILODRATE, DIMETHICONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)
Magnesium Aluminosilicates 200 mg
Magnesium Hydroxide 60 mg
Simethicone 20 mg

OTC - PURPOSE SECTION

Purposes
Magnesium Aluminosilicates    Antacid
Magnesium Hydroxide    Antacid
Simethicone    Antigas

INDICATIONS & USAGE SECTION

Uses relieves these symptoms

■heartburn ■acid indigestion ■sour stomach

■upset stomach and gas associated with these symptoms


WARNINGS SECTION

Enter section text here

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

■taking a prescription drug. Antacids may interact with certain prescription drugs


OTC - WHEN USING SECTION

When using this product

■Do not take more than 9 tablets in 24-hours period or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions
■Adults and children 12 years of age and over: Take 3 tablets with water 3 times daily between meals and at bedtime, or as directed by a doctor.
■Children under 12 years: Ask a doctor.

OTHER SAFETY INFORMATION

Other information  
■Each tablet contains: sodium 8 mg, magnesium 35 mg
■Do not purchase if printed seal with “sato” is broken or missing from top or bottom of carton.

INACTIVE INGREDIENT SECTION

Inactive ingredients  caramel, colloidal silicon dioxide, croscarmellose sodium, flavor, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, synthetic iron oxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1235450aluminum magnesium silicate 200 MG / magnesium hydroxide 60 MG / simethicone 20 MG Oral TabletPSN8
1235456INON ACE TABLETS 200 MG / 60 MG / 20 MG Oral TabletPSN8
1235456aluminum magnesium silicate 200 MG / magnesium hydroxide 60 MG / simethicone 20 MG Oral Tablet [Inon Ace Tablet]SBD8
1235450aluminum magnesium silicate 200 MG / magnesium hydroxide 60 MG / simethicone 20 MG Oral TabletSCD8
1235456Inon Ace Tablet (aluminum magnesium silicate 200 MG / magnesium hydroxide 60 MG / simethicone 20 MG) Oral TabletSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-402-01Inon Ace1 in 1 CARTONTABLET18
49873-402-01Inon Ace75 in 1 BOTTLETABLET758

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-402INON ACE (MAGNESIUM ALUMINOSILICATES, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET [SATO PHARMACEUTICAL CO., LTD.]8Current NDC, Legacy NDC, 2 package rows20231111_0af4355f-e160-409d-8471-2de98dbc6f7c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
dimethiconeACTIVE INGREDIENT92RU3N3Y1O5
magnesium hydroxideACTIVE INGREDIENTNBZ3QY004S5
SILODRATEACTIVE INGREDIENT9T3UU8T0QK5
dimethiconeACTIVE MOIETY92RU3N3Y1O5
magnesium cationACTIVE MOIETYT6V3LHY8385
silodrateACTIVE MOIETY9T3UU8T0QK5
caramelINACTIVE INGREDIENTT9D99G2B1R5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U5
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH485
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRT5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671P5
magnesium stearateINACTIVE INGREDIENT70097M6I305
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU45

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49873-40249873-402-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARAMELT9D99G2B1RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYDROXYPROPYL CELLULOSERFW2ET671PIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
SILODRATE9T3UU8T0QKACTIB
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
caramelCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii+route
12 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
caramelCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET / ORAL230 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
caramelCARAMELT9D99G2B1RSUSPENSION / ORAL111.12 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ferric oxide yellowFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
caramelCARAMELT9D99G2B1RCAPSULE / ORALNAExact identifier — unii+route
12 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
caramelCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET / ORAL230 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
caramelCARAMELT9D99G2B1RLIQUID / ORAL5.3 mgExact identifier — unii+route
12 equally ranked IID candidates
caramelCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
caramelCARAMELT9D99G2B1RSYRUP / ORAL207 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
caramelCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii+route
12 equally ranked IID candidates
caramelCARAMELT9D99G2B1RCAPSULE / ORALNAExact identifier — unii+route
12 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
caramelCARAMELT9D99G2B1RGRANULE, FOR SUSPENSION / ORAL2.5 mg/5mlExact identifier — unii+route
12 equally ranked IID candidates
caramelCARAMELT9D99G2B1RSOLUTION / ORAL11 mgExact identifier — unii+route
12 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Inon AceMAGNESIUM ALUMINOSILICATES, MAGNESIUM HYDROXIDE, SIMETHICONESato Pharmaceutical Co., Ltd.0af4355f-e160-409d-8471-2de98dbc6f7c2023-11-10WarningsExact identifier
ndc (package): 49873-402-01
ndc (product): 49873-402
ndc11 (package): 49873040201
spl id: 09d87d9c-fe4c-fd02-e063-6394a90a56bd
spl set id: 0af4355f-e160-409d-8471-2de98dbc6f7c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.